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Latest Media and Press

Article – FDA Braces for Looming Boom in Cell and Gene Therapy Submissions
Published By: BioSpace
Date: June 12, 2023
Author: Ana Mulero (BioSpace), with contributions from Greg Meyer and Kenneth Ndugga-Kabuye
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Article – US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development
Published By: Drug Discovery Today
Date: May 15, 2023
Authors: William Salminen, Olu Aloba, Angela Drew, Agnieszka Marcinowicz, and Madelyn Huang
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Article – Update on FDA regulation of ophthalmic combination products
Published By: Regulatory Focus
Date: January 31, 2023
Authors: Olu Aloba, Marianthi Karakatsani, and Laura Kilgore
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Article – Nitrosamines in pharmaceuticals: Scientific and regulatory status
Published By: Regulatory Focus
Date: August 31, 2022
Authors: Olu Aloba and Marianthi Karakatsani
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